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  drug FDA

Drug certification

FDA has a complete set of certification procedures for pharmaceutical products to ensure the safety and efficacy of new drugs. The procedure is as follows:

1. Research for new drugs (IND):

When the pharmaceutical company to the FDA to submit IND, FDA on the monitoring of new drugs began. At this time the new drug human experiment has not yet begun, FDA mainly audit in vitro safety data and animal experimental data to determine whether the drug is safe enough to enter the human experimental stage.

2. Human experiment:

Human trials are divided into four stages: the first major test drug safety, the main side effects, metabolic mechanism, etc., the number of samples is generally less than this 00.

The second phase of the main test of the effectiveness of drugs to determine whether the effective role of drugs in the human body at the same time, the safety of drugs and toxic side effects is also closely observed the object of the second phase of the sample is generally less than 300.

If the second phase of the experiment is encouraging, the larger sample will be tested and the experiment will proceed to Phase 3. The three phases will include different age groups, different populations, with different doses, with a comprehensive study drug safety The number of samples in the three experiments ranges from a few hundred to several thousand.

The fourth phase is mainly after the approval of the new drug, the main test drug long-term safety, new population, and so on.

3. New Drug Application (NDA):

When the pharmaceutical company completed the human experiment to verify the safety and effectiveness of the new drug, the FDA formally submitted to the FDA NDA application. FDA review all animal and human experimental data, as well as drug interpretation mechanism data, drug production GMP data, if the data Incomplete or unreasonable, the FDA will refuse to apply, otherwise the FDA will be completed in about 10 months nuclear, give consent or refused to give advice.

The above content from the "MTG FDA Certification Service Center Service Manual"

FDA certification process

1. the preparation phase

Copy of corporate legal person license;

Production (health) license, a copy of the certificate;

Company Profile (set up time, technical strength, the main product of extreme performance, asset status).

2. Technical preliminary examination report accepted

Submit the English translation of DMF (Drug Master File) and SOP (Standard Operating Procedures) to the Agent;

According to the views of agents, the above documents to be modified.

3. DMF data review

FDA carefully reviewed and went to the factory site inspection, check whether the DMF document is true;

If the FDA does not find any significant errors, and that meet the requirements, then put forward a pre-approval inspection plan.

4. FDA inspection

FDA inspectors check the factory, ask the factory must answer one by one;

If in doubt, the official will give "483" table (rectification proposal), the problem is serious, do not give "483" table.

5. FDA issued "approval letter"

It is necessary to seriously answer the question raised by the prosecutor on the "483" table. If there is a problem, it must be corrected and confirmed immediately;

Prosecutors do not understand the problem, need to explain the proof

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